510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OLYClass II

Magnetoencephalograph

21 CFR 882.1400 / Neurology
FDA source (opens on fda.gov)

OLY is the FDA product code for Magnetoencephalograph, a class II device type, regulated under 21 CFR 882.1400. FDA's definition for this code reads: "Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OLY
Device name
Magnetoencephalograph
FDA definition
Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code OLY

By decision year
6 clearances under product code OLY with a decision year between 1986 and 2020, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OLY by decision year
YearClearances
19861
19961
19971
20141
20161
20201

Applicants with the most clearances

Product code OLY
Applicants holding the most 510(k) clearances under product code OLY
ApplicantClearances
Biomagnetic Technologies, Inc.2
Tristan Technologies, Inc.2
Compumedics Limited1
Philips North America LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code